CPG Sec 540.275 (Draft) Crabmeat - Fresh and Frozen - Adulteration with Filth, Involving the Presence of Escherichia coli

Administrative draft guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

Guidance for FDA Staff
Compliance Policy Guide
Sec. 540.275 Crabmeat – Fresh and
Frozen – Adulteration with Filth,
Involving the Presence of
Escherichia coli
Draft Guidance
This guidance is being distributed for comment purposes only.
Although you can submit comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency considers your comment on this draft document
before it begins work on the final version of the guidance, submit either electronic or
written comments on the draft guidance within 60 days of publication in the Federal
Register of the notice announcing the availability of the draft guidance. Submit
electronic comments to http://www.regulations.gov. Submit written comments to the
Division of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with
the docket number listed in the notice of availability that publishes in the Federal
Register.
For questions regarding this draft document contact the Center for Food Safety and
Applied Nutrition (CFSAN) at 240-402-1421.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Regulatory Affairs
December, 2014

Contains Nonbinding Recommendations
Draft – Not for Implementation
Table of Contents
I. Introduction
II. Background
III. Policy
IV. Regulatory Action Guidance
V. 	Specimen Charges
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Contains Nonbinding Recommendations
Draft – Not for Implementation
Guidance for FDA Staff
Compliance Policy Guide
Sec. 540.275 Crabmeat – Fresh and Frozen –
Adulteration with Filth, Involving the Presence of
Escherichia coli
This draft guidance, when finalized, will represent the Food and Drug Administration's
(FDA's) current thinking on this topic. It does not create or confer any rights for or on
any person and does not operate to bind FDA or the public. You can use an alternative
approach if the approach satisfies the requirements of the applicable statutes and
regulations. If you want to discuss an alternative approach, contact the FDA staff
responsible for implementing this guidance. If you cannot identify the appropriate FDA
staff, call the telephone number listed on the title page of this guidance.
*I. Introduction:
The purpose of this document is to provide guidance for FDA staff on adulteration with
filth involving the presence of Escherichia coli in fresh and frozen crabmeat. In the
remainder of this guidance, “we” or “our” refers to FDA.
FDA’s guidance documents, including this guidance, do not establish legally enforceable
responsibilities. Instead, guidances describe FDA’s current thinking on a topic and
should be viewed only as recommendations, unless specific regulatory or statutory
requirements are cited. The use of the word should in FDA guidances means that
something is suggested or recommended, but not required.
II. Background:
Escherichia coli (E. coli) has traditionally been used as a microbiological indicator of
insanitation during processing. E. coli is commonly associated with feces of warm
blooded animals. Its presence in foods and water suggests fecal contamination. In the
production of commercially processed fresh or frozen crabmeat, the cook step (boiling or
steaming the in-shell crabs) destroys nonsporeforming bacteria including E. coli, if they
are present on the raw product. Therefore, the presence of E. coli in finished product
indicates that either the cook step was inadequate or the product was recontaminated after
the cook step. As applied to fresh or frozen crabmeat discussed in this CPG, cooking is a
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Contains Nonbinding Recommendations
Draft – Not for Implementation
heat treatment, usually performed before the product is placed in the finished product
container and distributed either refrigerated or frozen.
Recontamination of the crabmeat after the cook step could be a result of either insanitary
practices by the employees in the processing plant or the presence of insects in the
processing plant that may have served as vectors for the dissemination of bacteria to the
food after the cook step. Strict in-plant sanitation measures should be instituted to
prevent the presence of E. coli in the finished product. Although most strains of E. coli
are harmless, some strains can cause severe illness. The confirmed presence of E. coli at
levels of 3.6 Most Probable Number per gram (MPN/g) or greater in crabmeat indicates
insanitary conditions, which may include poor employee hygiene practices, improperly
sanitized utensils and equipment, or insects or other pests.
III. Policy:
FDA may consider that crabmeat has been prepared, packed, or held under insanitary
conditions whereby it may have been contaminated with filth and, thus, is adulterated
under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 342(a)(4)) when, based on examination of a sample consisting of a minimum
of six subsamples of fresh or frozen crabmeat:
• 	E. coli at levels of 3.6 MPN/g or greater is present in two or more of six
subsamples, with or without inspectional evidence to indicate the most probable
source of the E. coli, or
• 	E. coli at levels of 3.6 MPN/g or greater is present in only one of six subsamples,
and available inspectional evidence indicates the most probable source of the E.
coli (i.e., evidence demonstrating an inadequate cook step or likely contamination
after cooking.) Such inspectional evidence may include observed insanitary
conditions, such as poor employee hygiene practices, improperly sanitized
utensils and equipment, the presence of insects or other pests, and possible routes
of contamination of the cooked crabs or crabmeat (e.g., contact between raw
crabmeat and cooked crabs or crabmeat).
Under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)), FDA may refuse
admission of crabmeat that is offered for import into the United States and that appears to
be adulterated within the meaning of section 402(a)(4) of the FD&C Act.
IV. Regulatory Action Guidance:
Direct Reference
The following represents criteria for direct reference seizure submission to Office of
Regulatory Affairs (ORA), Office of Enforcement and Import Operations, Division of
Enforcement (OEIO/DE) and for direct reference import refusal by the District to ORA,
Office of Enforcement and Import Operations, Division of Import Operations
(OEIO/DIO):
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Contains Nonbinding Recommendations
Draft – Not for Implementation
When upon examination of a sample consisting of a minimum of six subsamples of
fresh or frozen crabmeat, E. coli at levels of 3.6 MPN/g or greater is present in two or
more of six subsamples, with or without inspectional evidence to indicate the most
probable source of the E. coli.
Recommendations
The following represent criteria for recommending seizure or import refusal to CFSAN,
Office of Compliance, Division of Enforcement (HFS-605):
When upon examination of a sample consisting of a minimum of six subsamples of
fresh or frozen crabmeat, E. coli at levels of 3.6 MPN/g or greater is present in only
one of six subsamples, and available inspectional evidence indicates the most
probable source of the E. coli.
Available inspectional evidence indicating the most probable source of the E. coli (i.e.,
evidence demonstrating an inadequate cook step or likely contamination after cooking)
should be included in the recommendation. Such inspectional evidence may include
observed insanitary conditions, such as poor employee hygiene practices, improperly
sanitized utensils and equipment, the presence of insects or other pests, and potential
routes of contamination of the cooked crabs or crabmeat (e.g., contact between raw
crabmeat and cooked crabs or crabmeat).
While assessing recommendations based on the criteria above, the Division of
Enforcement will also assess whether a charge under section 402(a)(3) of the FD&C Act
(21 U.S.C. 342(a)(3)) can be supported.
V. Specimen Charges:
Domestic Seizure
The article of food was adulterated when introduced into and while in interstate
commerce and is adulterated while held for sale after shipment in interstate commerce,
within the meaning of 21 U.S.C. 342(a)(4), in that the food has been prepared, packed,
and held under insanitary conditions whereby it may have been contaminated with filth.
Import Refusal
The article of food is subject to refusal of admission pursuant to section 801(a)(3) of the
FD&C Act in that it appears to be adulterated within the meaning of section 402(a)(4) of
the FD&C Act in that it has been prepared, packed, or held under insanitary conditions
whereby it may have become contaminated with filth.*
*Material between asterisks is new or revised*
Issued: 10/1/82
Revised: 10/30/89, 3/95, 5/2005, 11/29/2005, [insert date]
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